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Winston-Salem,
North Carolina27157

Purpose:

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to
stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Cholecalciferol (vitamin D) may help cancer cells become normal cells. Giving
arsenic trioxide together with cholecalciferol (vitamin D) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with
cholecalciferol (vitamin D) works in treating patients with myelodysplastic syndromes.

Study summary:

OBJECTIVES:
Primary
- Determine the complete response rate and the rate of hematological improvement in
patients with myelodysplastic syndromes treated with arsenic trioxide and
cholecalciferol (vitamin D).
Secondary
- Determine the safety of this regimen in these patients.
- Determine the time to progression to acute myeloid leukemia, defined as blast ≥ 20%, in
patients treated with this regimen.
- Determine overall survival and progression-free survival of patients treated with this
regimen.
- Determine the effect of this regimen on bone marrow and peripheral blood mononuclear
cell apoptosis and p21 protein expression in these patients.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive oral cholecalciferol (vitamin D)* once daily on days 1-28. Patients also
receive arsenic trioxide IV over 1-4 hours on days 1-5 (week 1) and then twice weekly for 3
weeks (weeks 2-4) for course 1 and twice weekly for 4 weeks for all subsequent courses.
Courses repeat every 28 days for up to 12 months in the absence of disease progression or
unacceptable toxicity.
NOTE: * Patients who do not achieve a complete hematologic response receive escalating doses
of cholecalciferol (vitamin D) at 3, 6, and 9 months during therapy in the absence of
disease progression and unacceptable toxicity.
At the completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study.